• Amsterdam Molecular Therapeutics BV (AMT), of Amsterdam, the Netherlands, licensed from Digna Biotech SL, of Pamplona, Spain, the right to commercialize gene therapy products developed at the Center for the Study of Applied Medicine at the University of Navarra, Spain. AMT plans to start preclinical studies next year on the first program to emerge from the collaboration, an adeno-associated viral vector delivering insulin-like growth factor I (IGF-I) for late-stage liver cirrhosis. Separately, AMT said it completed enrollment of 14 patients in a clinical trial of its lead gene therapy product, AMT-011, for deficiency of the lipoprotein lipase (LPL) gene. AMT expects to apply for regulatory approval of AMT-011 in the first half of 2008.

• Anavex Life Sciences Corp., of Geneva, said preclinical studies of ANAVEX 1-41, its lead drug candidate for Alzheimer's disease, showed the compound prevented oxidative stress, which damages and destroys cells and is believed to be a primary cause of Alzheimer's disease. It also prevented the expression of caspase-3, an enzyme that plays a key role in programmed cell death and in the loss of cells in the hippocampus, the part of the brain that regulates learning, emotion and memory. Testing was conducted in a nontransgenic mouse model of Alzheimer's disease. The preclinical studies will be completed in the coming weeks, and the company plans an investigational new drug application filing so that human trials can begin.

• Avexa Ltd., of Melbourne, Australia, said a series of in vitro experiments showed that its lead product, ATC, maintains potent antiviral activity against HIV strains that are resistant to integrase inhibitors, including raltegravir, the recently approved integrase inhibitor from Whitehouse Station, N.J.-based Merck & Co. Inc. ATC (apricitabine) has completed dosing in a Phase IIb trial, and Avexa anticipates starting a Phase III program by the end of this year.

• Bavarian Nordic, of Kvistgard, Denmark, said it will receive a $25 million milestone payment from the Department of Health and Human Services as part of a contract to manufacture and deliver 20 million doses of Imvamune smallpox vaccine. The payment will be recognized as revenue in the firm's financial statements for 2007. Bavarian Nordic previously received an advance payment of $50 million under the contract and expects to receive an additional $25 million milestone payment from the U.S. government before the end of the year.

• Binex Co. Ltd., of Busan, South Korea, and MaxCyte Inc., of Gaithersburg, Md., signed a sponsored research agreement to evaluate MaxCyte's GMP-compliant cell-loading technology for use in the closed-system manufacturing of Binex's cell-based cancer immunotherapies. Upon completion of the research studies, the deal provides Binex an option to license MaxCyte's technology for clinical and commercial use in Korea. Financial terms were not disclosed.

• BioAlliance Pharma SA, of Paris, extended its ongoing Phase III clinical trial of acyclovir Lauriad in the indication of oral herpes to the U.S. Ten clinical centers have been opened there and will join the 40 or so in Australia and Europe already participating in the trial. The aim is to enroll a total of 640 patients. The company is planning to file for market approval of acyclovir Lauriad in both Europe and the U.S. in the first half of 2009. In addition, BioAlliance is continuing to open additional centers in Europe for its Phase III trial of doxorubicin Transdrug in the indication primary liver cancer.

• Celgene International Sarl, of Boudry, Switzerland, said Revlimid (lenalidomide) was granted orphan drug status by the European Commission in chronic lymphocytic leukemia. That designation provides for regulatory assistance and 10 years of marketing exclusivity upon approval.

• ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, said it received shareholder approval of its previously announced plan to de-merge its metabolic disease business, Autogen Research Ltd., and merge it with Queensland, Australia-based Adipogen Pharmaceuticals Pty. Ltd. The new combined company will operate as Verva Pharmaceuticals Ltd. The move will allow ChemGenex to focus on its cancer portfolio, including the Phase II/III chronic myeloid leukemia drug omacetaxine mepesuccinate.

• Chroma Therapeutics Ltd., of Oxford, UK, reported efficacy data from a Phase I trial of its oral, once-daily aminopeptidase inhibitor CHR-2797 in treating acute myeloid leukemia at the American Society of Hematology meeting. The company also presented the results of various preclinical studies

• Evotec AG, of Hamburg, Germany, has completed the sale of its chemical development business to Aptuit Inc., of Greenwich, Conn., for £31.5 million (US$65 million) effective Nov. 30. Evotec said it will focus more on discovery collaborations and partnering of preclinical and clinical programs developed internally. Evotec is in the process of closing on its $151.8 million stock deal to buy Renovis Inc., of South San Francisco.

• Galapagos NV, of Mechelen, Belgium, said it is collaborating with the Cystic Fibrosis Foundation Therapeutics Inc., of Bethesda, Md., to discover new therapies for cystic fibrosis in a deal worth up to €5.5 million (US$8.1 million). The collaboration aims to identify small molecules derived from natural sources that improve the function of cystic fibrosis transmembrane conductance regulator, a defective protein found in cystic fibrosis patients.

• Graffinity Pharmaceuticals GmbH, of Heidelberg, Germany, entered a second collaboration with New York-based Pfizer Inc. focused on Graffinity's fragment-based drug discovery technology. Specific terms were not disclosed, though Graffinity will receive technology access fees and payments for the generation of small-molecule hits against a number of drug targets.

• GW Pharmaceuticals plc, of Salisbury, UK, said it started the new Phase III trial of Sativex in multiple sclerosis spasticity requested by the UK regulator when it refused approval for the cannabis-based treatment in July. The Medicines and Healthcare Regulatory Agency (MHRA) asked for a further trial because, it said, the benefit obtained by those who responded in any way to the treatment was masked by the mean improvement across the whole of the patient population, which included nonresponders. It is possible to identify patients who have responded within four weeks of treatment starting, and the MHRA has asked for a trial in which responders are first identified and then randomized into treatment and nontreatment groups to confirm that the benefit is greater than placebo when responders only are treated. The study aims to report headline results toward the end of 2008.

• Immutep SA, of Orsay, France, reported positive interim results from a Phase I/II clinical trial of ImmuFact IMP321 in the indication of metastatic breast cancer. ImmuFact IMP321 is a natural human T-cell immunostimulatory factor that amplifies the T-cell immune response in therapeutic vaccines through the activation of dendritic cells and more efficient antigen presentation to T cells. The product has been tested in six different cancer indications over the past two and a half years, but this was the first in which it was tested as a complementary immunotherapy to chemotherapy. The clinical outcome was tumor regression in six of the eight patients treated and disease stabilization in one other, which compares with a response rate of 35 percent with chemotherapy alone.

• Innovex UK Ltd., of Bracknell, UK, the marketing arm of Quintiles Transnational Corp., entered an agreement with Zeltia SA subsidiary PharmaMar SA, of Madrid, Spain, to recruit, train and deploy a specialized oncology sales team in Western Europe to promote Yondelis, PharmaMar's treatment for soft-tissue sarcoma. PharmaMar will be responsible for marketing the drug, which was launched earlier this year in the UK and Germany. Financial terms were not disclosed.

• LipoNova AG, of Hanover, Germany, signed a memorandum of understanding with an unnamed, non-European pharmaceutical company for development and marketing of Reniale, LipoNova's autologous vaccine for renal cell carcinoma. The partner will support a planned Phase III trial with the drug and make milestone and royalty payments in exchange for an exclusive license in an undisclosed non-European country. Specific terms were not disclosed.

• MediGene AG, of Martinsried, Germany, and Celltrion Inc., of Munich, Germany, signed a binding memorandum of understanding for co-development and commercialization of an anti-L1 monoclonal antibody for the treatment of cancer in humans covering major cancer indications. The companies will share responsibilities for development and commercialization. Celltrion will conduct process development and manufacturing and will have exclusive responsibility for development and commercialization of the L1 MAb in Asia, including Japan. Celltrion also will have an option for global manufacturing rights to supply Phase III and commercial material. MediGene retains the rights for the development and commercialization of the product in Europe, the U.S. and the remaining areas. MediGene will have the right to exercise an option to acquire an exclusive worldwide license on the application of the anti-L1 monoclonal antibody in antitumor therapy.

• Oasmia Pharmaceutical, of Sweden, and Orion Corp., of Finland, have entered a license and distribution agreement for marketing and sales of Paclical (micellar paclitaxel) in the Nordic region, encompassing Sweden, Denmark, Norway, Finland and Iceland. The product is entering Phase III development for ovarian cancer. Under the agreement, Orion will receive the exclusive rights in the Nordic region to distribute and sell the product. It also will have first right of refusal for one more cancer drug candidate in the Oasmia product portfolio in the Nordic region. According to the agreement, Oasmia will receive payments of €4 million (US$5.9 million), partly up front and partly subject to a successful development and regulatory process for Paclical as royalties from the sales. Oasmia will be responsible for the clinical development, registration and production of Paclical. Orion will be responsible for the distribution and sales in the Nordic region after registration.

• Onyvax Ltd., of London, said it has been issued a U.S. patent on Onycap23, a prostate cancer cell line. Onycap23 is a key component of Onyvax-P, the company's prostate cancer vaccine that is currently in two Phase IIb clinical trials.

• Pronova BioPharma ASA, of Lysaker, Norway, said the Federal Patent Court in Munich, Germany, declared the company's patent covering the active pharmaceutical ingredient of Omacor invalid. That decision follows the nullity action brought by KD Pharma Bexbach GmbH and Institute Biochimique SA against Pronova in June 2006. Pronova said it will appeal the ruling and that the decision will not affect its right to supply and sell Omacor in Germany. Omacor, an omega-3-derived drug approved in the U.S. and Europe for hypertriglyceridemia, is distributed through several partners, including Reliant Pharmaceuticals Inc., of Liberty Corner, N.J., which sells the product in the U.S. as Lovaza.

• S*BIO Pte Ltd., of Singapore, said it expanded its pipeline with a third development candidate, SB1317, an oral, small molecule for acute leukemias. SB1317, which is designed to selectively inhibit major signaling pathways involving FLT3 and CDK, is positioned to treat relapsed and refractory acute leukemias. The product has entered preclinical development.

• Speedel Holding Ltd., of Basel, Switzerland, said it received from Novartis AG, also of Basel, the revenue report regarding SPP100, confirming that it earned CHF621,000 (US$555,274) for the third quarter, which was higher than the projected CHF571,000 the company previously announced with its financial results. The report also included details on the cost-of-goods savings, which Novartis has achieved for products sold during the third quarter using the chemical synthesis route developed by Speedel and licensed to Novartis in 2002. A small portion of the product sold by Novartis in the third quarter was reported to be eligible for the savings on cost of goods stipulated in the licensing agreement.

• Starpharma, of Melbourne, Australia, has signed a collaborative research agreement with Stiefel Laboratories Inc., of Coral Gables, Fla., to apply Starpharma's dendrimer nanotechnology to certain drugs used dermally. The collaboration applies Starpharma's dendrimer technology to deliver drugs through the skin with the aim of improving the effectiveness and tolerability of some dermal treatments. Starpharma will receive staged payments on successful completion of technical milestones. The agreement also deals with commercialization rights arising from the collaboration. No financial details were disclosed.

• Tripos Discovery Research Ltd., of Bude, UK, said it changed its name to Exelgen Ltd. The firm said that the new name is a hybrid that reflects the firm's real value proposition of excellence in the genesis of new and innovative drug discovery paradigms.

• Xenome Ltd., of Brisbane, Australia, signed a joint research collaboration agreement with Amylin Pharmaceuticals Inc., of San Diego, focusing on discovery and development of novel peptide therapeutics for metabolic and musculoskeletal diseases. In addition, Amylin has made an equity investment in Xenome matched by investments from Queensland BioCapital Funds and Innovis Australia. Under the collaboration, Amylin will apply its proprietary screening technologies to evaluate the therapeutic potential of the peptides from Xenome's bioactive peptide library derived from natural sources. Amylin will have the right to select and exclusively license lead candidates resulting from a screening program in metabolic and musculoskeletal disease for further development and commercialization in exchange for milestones and royalties paid to Xenome. Financial details were not disclosed. Separately, Xenome raised $10 million of equity finance. The syndicated funding round includes its major investor, Queensland BioCapital Funds, for $2.7 million, equity funding of $5 million from Amylin and $2.3 million from Innovis Investment Partners.